Clinical trial · Interventional
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
NCT02384434CI-TRIAL-00091473completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THOR Laser System for Low Level Laser Therapy (LLLT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Low Level Laser Therapy
- description
- Non-invasive, cold laser output treatment.
- interventionNames
- Device: THOR Laser System for Low Level Laser Therapy (LLLT)
Primary outcomes (1)
- measure
- Grade 3 or Higher Adverse Events
- timeFrame
- Up to 12 months
- description
- Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
Secondary outcomes (21)
- measure
- University of Washington Quality of Life Questionnaire (UW-QOL)
- timeFrame
- At Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients ≥ 18 years of age * Karnofsky performance status \> 70 * Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * No prior radiotherapy to the head and neck region. * No previous systemic chemotherapy or targeted therapy * Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts. * Patients using standard therapies for cetuximab-induced acne-form rash will be included. Exclusion Criteria: * Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies * Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator * Concurrent serious infection * Continued use of Niacin
References
Publications (0)
Data not yet available
No reference posted for this study.